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Opinion Contributor

Court case could undermine drug approval process

Crucial legal and medical principles hang in the balance with this case, the author writes. | AP Photo

The case involving Mutual Pharmaceutical also challenges prior legal precedent; in particular a 2011 decision in Pliva Inc. v. Mensing, in which the high court ruled 5-4 that certain state tort claims against generic drugmakers are pre-empted by federal law. Because the FDA requires generics to use the same ingredients and labeling as the branded drugs they’re copied from, the court said that the makers of generic drugs couldn’t be held liable as a matter of state tort law for “failing to warn” consumers of risks.

That prior ruling is what set the trial bar searching for new ways to bring tort cases against generic drugmakers. The “design defect” theory is the latest step in that effort. In hearing the original appeal of the current case, the appellate court openly said that it was challenging, if not refusing to follow the high court’s prior ruling.

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The administration decision to side — albeit cautiously — against the trial bar is significant. The entire case could well decide whether “design defect” claims will become the next product liability bonanza. While the Supreme Court, in deciding whether to affirm the 1st Circuit decision, will only influence whether these “design defect” claims can be made against generic drugs, the high court could issue dicta that would help makers of branded drugs forced to face similar suits.

It’s one reason why those branded drugmakers have filed their own brief in the case, alongside the administration. The case has made for strange bedfellows, underscoring the crucial legal and medical principles that hang in the balance.

Scott Gottlieb, a physician and resident fellow at the American Enterprise Institute, was FDA deputy commissioner from 2005 to 2007.